Physiological StressNCT07840144
Lower Body Negative Pressure to Validate Physiological Monitors
A study testing Lower Body Negative Pressure with Noninvasive Physiological Monitoring in people with Physiological Stress, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to test the accuracy of non-invasive physiological monitors while the body responds to different levels of lower body negative pressure (LBNP). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiological Stress
- What is being tested?
- Lower Body Negative Pressure with Noninvasive Physiological Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to 28 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-obese (BMI<30)
- Non-smokers
- Free of any systemic diseases including hypertension, diabetes, coronary artery disease, neurologic disease, or any other major medical co-morbidity.
- Women will be either surgically sterilized or non-pregnant as determined by a urine pregnancy test (within 48 hours of the study day)
Who cannot join
- Individuals taking GLP-1 medications or compounds known to affect responses of the autonomic nervous system to orthostatic stress (e.g., β-blockers)
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Pamela Engrav, 507-255-6938
About this study
The purpose of this research is to test the accuracy of non-invasive physiological monitors while the body responds to different levels of lower body negative pressure (LBNP).
- Conditions
- Physiological Stress
- Being tested
- Lower Body Negative Pressure with Noninvasive Physiological Monitoring
- Keywords
- Hemodynamic Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower Body Negative Pressure with Noninvasive Physiological MonitoringDiagnostic test
Participants will undergo a graded lower body negative pressure protocol using suction levels of 15, 30, 45, 60, 70, 80, 90, and 100 mmHg, each for up to 5 minutes or until presyncopal symptoms or other termination criteria occur. During the procedure, validated reference physiological measurements and investigational noninvasive monitor signals will be collected simultaneously.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers Undergoing Lower Body Negative Pressure | Experimental | Healthy adult participants will complete one study visit involving graded lower body negative pressure while standard physiological reference measurements and noninvasive investigational physiological monitor data are collected. Receives: Diagnostic Test: Lower Body Negative Pressure with Noninvasive Physiological Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Oxygen Saturation During Lower Body Negative Pressure
Arterial oxygen saturation will be measured during lower body negative pressure using noninvasive physiological monitors
Measured: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes
ECG Waveform During Lower Body Negative Pressure
ECG waveform will be measured during lower body negative pressure using noninvasive physiological monitor
Measured: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes
Respiratory Rate During Lower Body Negative Pressure
Respiratory rate will be measured during lower body negative pressure using noninvasive physiological monitors
Measured: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes
Plethysmography Signals During Lower Body Negative Pressure via physiological monitors
Plethysmography signals will be measured during lower body negative pressure from the pulse oximetry. Reported as a non-invasive research metric of central blood volume.
Measured: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes
Heart rate During Lower Body Negative Pressure
Heart rate will be measured during lower body negative pressure using noninvasive physiological monitors
Measured: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion28 Sep 2028 (estimated)
- Study completion28 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological StressStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Joyner, M.D., Mayo Clinic
- Investigators
- Michael J. Joyner, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840144
- Sponsor's protocol ID
- 26-007152
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Body Negative Pressure to Validate Physiological Monitors
- ClinicalTrials.gov ID
- NCT07840144
- Acronym / sponsor ID
- 26-007152
- Conditions
- Physiological Stress
- Keywords
- Hemodynamic Monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 28 Sep 2028 (estimated)
- Study completion
- 28 Sep 2028 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to test the accuracy of non-invasive physiological monitors while the body responds to different levels of lower body negative pressure (LBNP).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers Undergoing Lower Body Negative Pressure | Experimental | Diagnostic Test: Lower Body Negative Pressure with Noninvasive Physiological MonitoringHealthy adult participants will complete one study visit involving graded lower body negative pressure while standard physiological reference measurements and noninvasive investigational physiological monitor data are collected. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Non-obese (BMI<30)
- Non-smokers
- Free of any systemic diseases including hypertension, diabetes, coronary artery disease, neurologic disease, or any other major medical co-morbidity.
- Women will be either surgically sterilized or non-pregnant as determined by a urine pregnancy test (within 48 hours of the study day)
Key exclusion criteria (2 listed)
- Individuals taking GLP-1 medications or compounds known to affect responses of the autonomic nervous system to orthostatic stress (e.g., β-blockers)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower Body Negative Pressure with Noninvasive Physiological MonitoringParticipants will undergo a graded lower body negative pressure protocol using suction levels of 15, 30, 45, 60, 70, 80, 90, and 100 mmHg, each for up to 5 minutes or until presyncopal symptoms or other termination criteria occur. During the procedure, validated reference physiological measurements and investigational noninvasive monitor signals will be collected simultaneously. | Diagnostic test | Healthy Volunteers Undergoing Lower Body Negative Pressure |
Primary outcome
Arterial Oxygen Saturation During Lower Body Negative Pressure
Time frame: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes
Arterial oxygen saturation will be measured during lower body negative pressure using noninvasive physiological monitors
ECG Waveform During Lower Body Negative Pressure
Time frame: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes
ECG waveform will be measured during lower body negative pressure using noninvasive physiological monitor
Respiratory Rate During Lower Body Negative Pressure
Time frame: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes
Respiratory rate will be measured during lower body negative pressure using noninvasive physiological monitors
Plethysmography Signals During Lower Body Negative Pressure via physiological monitors
Time frame: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes
Plethysmography signals will be measured during lower body negative pressure from the pulse oximetry. Reported as a non-invasive research metric of central blood volume.
Heart rate During Lower Body Negative Pressure
Time frame: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes
Heart rate will be measured during lower body negative pressure using noninvasive physiological monitors
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael J. Joyner, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower Body Negative Pressure with Noninvasive Physiological Monitoring in people with Physiological Stress, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pamela Engrav (507-255-6938, engrav.pamela@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial Oxygen Saturation During Lower Body Negative Pressure (time frame: During the single study visit, from baseline through completion of the lower body negative pressure protocol, up to 40 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.